The Australian Therapeutic Goods Administration (TGA) has approved Epidyolex (cannabidiol) as a treatment for seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients 2 or older, according to developers GW Pharmaceuticals.
In order to make Epidyolex available to Australian patients, GW has partnered with Chiesi Australia, and plans to work with the Pharmaceutical Benefits Advisory Committee (PBAC) to list the medication in the Pharmaceutical Benefits Scheme (PBS), which would allow the government to subsidize the cost of Epidiolex for consumers.
“GW was founded over two decades ago with a mission to bring cannabis-based medicines to patients with an unmet medical need,” said Chris Tovey, GW’s chief operating officer, in a press release. “We are proud to now be able to bring GW’s cannabidiol to patients in Australia following this approval and our partnership with Chiesi Australia.”
The active ingredient of Epidyolex is cannabidiol, a type of molecule that is derived from the cannabis plant. Though cannabidiol is derived from cannabis, the molecule does not have psychoactive properties, meaning theire is no “high” associated with using it. Cannabidiol, however, has been shown to improve seizure symptoms, potentially by acting on the endocannabinoid system (ECS) of the central nervous system.
Epidyolex’s approval was based on results from four Phase 3 clinical trials, which included more than 714 patients with either LGS and Dravet, both considered to be rare and severe forms of epilepsy.
The clinical program for Epidyolex, which led to its approval, included three randomized, controlled Phase 3 clinical trials (NCT02091375, NCT02224703, and NCT02224560) and the GWPCARE5 open-label extension study (NCT02224573).
Epydiolex was found to be efficient and have an acceptable safety profile as add-on anti-epileptic treatment in people with Dravet — at a dose of 20 mg/kg/d — and in patients with LGS at doses of 10 and 20 mg/kg/d.
A new Phase 4 study (NCT04133480, and not yet recruiting) will specifically evaluate whether Epidyolex treatment influences cognitive ability in patients between the ages of 3 and 10.
Known as Epidiolex in the U.S, the therapy was approved by the U.S. Food and Drug Administration (FDA) and now is available to treat LGS and Dravet patients 1 or older. In the EU, Epidyolex was approved in 2019 for patients 2 or older as a supplement to clobazam (an anti-convulsant medication).
“This marks our third global regulatory approval and is another important step for GW and the patients we are here to support,” said Tovey. “The TGA approval is further proof that cannabis-based medicines can successfully go through extensive randomised placebo-controlled trials and a rigorous evaluation process to reach patients who need them.”
Following the TGA’s approval and the partnership between GW and Chiesi Australia, the companies are working with the Australian Department of Health to ensure access to Epidyolex across Australia.
“We are delighted to announce the TGA registration of Epidyolex, an important step forward for the management of LGS and Dravet syndrome,” said Chris Rossidis, general manager of Chiesi Australia. “We are working closely with the Department of Health to achieve greater access to this medicine as soon as possible.”